A Phase 4 interventional study of 1,25 (OH)2 D3 and Inspiratory isometric resistance training in Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Supportive care
This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 63 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Mayo Clinic is the lead sponsor of 3,270 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo for eight weeks
Other: Inspiratory isometric resistance training · Drug: Oral Placebo · Device: Threshold Inspiratory Muscle Trainer (IMT)
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25 (OH)2 D3 orally for eight weeks
Drug: 1,25 (OH)2 D3 · Other: Sham Inspiratory Isometric Resistance Training · Device: Threshold Inspiratory Muscle Trainer (IMT)
Inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus 1,25(OH)2 D3 orally for eight weeks
Drug: 1,25 (OH)2 D3 · Other: Inspiratory isometric resistance training · Device: Threshold Inspiratory Muscle Trainer (IMT)
Sham inspiratory isometric resistance training with the Threshold Inspiratory Muscle Trainer (IMT) plus oral placebo orally for eight weeks
Drug: Oral Placebo · Other: Sham Inspiratory Isometric Resistance Training · Device: Threshold Inspiratory Muscle Trainer (IMT)
0.25 micrograms, taken daily for eight weeks, orally
Also known as: Calcitriol, 1, 25-dihydroxycholecalciferol, Rocaltrol
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).
Placebo will be created to mimic the appearance of the study drug
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.
A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
Also known as: Threshold IMT Breathing Trainer
Sniff Nasal Inspiratory Pressure (SNIP)
SNIP is a test of maximal inspiratory muscle force exerting from the diaphram. Patients sniff forcefully through one nostril while the other is obstructed. The best of 10 measurements is recorded.
Time frame: 8 weeks
A study coordinator worked closely with Dr. Jatoi in numerous clinics in the Division of Medical Oncology to identify potential candidates for this study.
| Milestone | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo |
|---|---|---|---|---|
| Started | 16 | 15 | 15 | 17 |
| Completed | 14 | 15 | 15 | 16 |
| Not completed | 2 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 1 |
SNIP is a test of maximal inspiratory muscle force exerting from the diaphram. Patients sniff forcefully through one nostril while the other is obstructed. The best of 10 measurements is recorded.
| cmH20 | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo |
|---|---|---|---|---|
| Sniff Nasal Inspiratory Pressure (SNIP) | 90 (51 to 190) | 87 (51 to 159) | 89 (43 to 150) | 109 (74 to 153) |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Training and Placebo | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Sham Training and Vitamin D3 Metabolite | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Training and Vitamin D3 Metabolite | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Sham Training and Placebo | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 11 | 15 | 51 |
| >=65 years | 3 | 3 | 4 | 2 | 12 |
| Age, Continuous(years) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| Mean | 52.5 (34 to 72) | 58 (42 to 81) | 55 (31 to 74) | 51 (26 to 75) | 54 (26 to 81) |
| Sex: Female, Male(Participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| Female | 13 | 12 | 13 | 12 | 50 |
| Male | 3 | 3 | 2 | 5 | 13 |
| Race/Ethnicity, Customized(Participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Training and Placebo | Sham Training and Vitamin D3 Metabolite | Training and Vitamin D3 Metabolite | Sham Training and Placebo | Total |
|---|---|---|---|---|---|
| United States | 14 | 15 | 15 | 16 | 60 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in May 2020, 23 months.
Results were first posted in Sep 2023, 3 years 4 months after primary completion.
Of 64 non-industry phase 4 interventional studies under Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 56. This study's 23 months is below that.
Counting every sponsor, half of 88 studies reached it within 38 months; a quarter within 21 and three quarters within 64.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcitriol